Senior Scientist, Formulations
Job Locations: US-FL-Coral Springs
More information about this job:
Lupin Pharmaceuticals Inc. is a specialty pharmaceutical company marketing generic and branded pharmaceutical products as
well as Active Pharmaceutical Ingredients (APIs) from its sales and marketing headquarters in Baltimore, MD.
Lupin Inc. has established a new Research and Development Center in the US located in Coral Springs, FL. This center will
focus on the development of generic and branded pharmaceutical products.
Independently conducts standard and advanced laboratory activities including evaluation and selection of raw materials
(APIs, excipients, primary and secondary packaging material, device component material etc.); pre-formulation and
formulation development studies for solutions, suspensions, bulk and formulated powder and propellant based formulations
for orally inhaled products following cGMP, Lupin EH&S and other relevant guidelines. Develops and evaluates new
formulation technologies where required.
- Independently set up and operate laboratory equipment, conduct instrument and analytical method troubleshooting.
- Prepare and maintain accurate records in lab notebooks of all testing performed. Analyze data, identify trends and
- perform statistical analysis.
- Write protocols, methods, standard operation procedures, and contribute to submission documents independently. Design
- experimental studies and write reports with minimal supervision.
- Participate in project activities and support project timelines and proactively contribute to meeting the team
- objectives. Communicate effectively with team members and internal or external customers. Work and communicate
- effectively with other functional groups. Lead broad project tasks effectively, with minimal supervision.
- Independently design studies and conduct evaluation and selection of raw material (APIs, excipients, primary and
- secondary packaging material, device component material etc.).
- Independently design studies and conduct pre-formulation and formulation development studies for solutions, suspensions,
- emulsions, bulk and formulated powders, propellant driven formulations for metered dose inhalers (MDIs).
- Support manufacturing activities and troubleshoot technical issues during manufacture of Dry Powder Inhaler (DPI),
- Metered Dose Inhaler (MDI) and nebulizer drug products.
- Independently investigate and recommend corrective actions for deviations, out-of-specification and out-of-trend results.
- Support the evaluation and introduction of new technologies; be capable of generating new practical ideas; possess good
- understanding of experimental design.
- Coach, train and support junior laboratory staff. Establish and maintain effective relationships with team members.
- Conduct lab work in accordance with SOPs; assure compliance to Lupin Quality procedures and follow Lupin safety rules and
- procedures. Comply with all Lupin Corporate guidelines and policies.
- PhD in Pharmaceutics/Pharmaceutical Chemistry/Analytical Chemistry or related discipline with 5+ years, MS with 10+years,
- or BS with a minimum of 15+ years pre-formulation and formulation research experience in the pharmaceuticalfield.
- Must have prior experience with pre-formulation and formulation research and relevant training in analytical
- Knowledge and understanding of the FDA cGMP requirements as they apply to the Pharmaceutical industry. Excellent
- understanding of USP methodologies and ICH guidelines.
- Strong English language skills including writing ability and oral communication.
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